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Study on the Long-term Safety of Cenobamate for Patients with Primary Generalized Tonic-Clonic Seizures

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What is this study about?

This clinical trial is focused on studying the long-term safety of a treatment for people with Primary Generalized Tonic-Clonic Seizures, a type of seizure that affects the whole brain and causes convulsions. The treatment being tested is called Cenobamate, which is used as an additional therapy to help manage these seizures. Cenobamate is available in different forms, including tablets and oral suspension, and is also known by the code name YKP3089.

The purpose of this study is to evaluate how safe and tolerable Cenobamate is for individuals with this type of seizure. Participants in the study will receive either Cenobamate or a placebo, which looks like the real medication but does not contain the active substance. The study will monitor participants over a period to observe any side effects or changes in their health. This will help researchers understand the long-term effects of using Cenobamate as a treatment.

Throughout the study, participants will take the medication by mouth, either as a tablet or an oral suspension. The study will last for a set period, during which participants will have regular check-ups to assess their health and any potential side effects. The goal is to ensure that Cenobamate is a safe option for managing Primary Generalized Tonic-Clonic Seizures over an extended period.

1 joining the study

Participation begins after successful completion of the previous study phase, known as the Double-blind Treatment Period.

Written informed consent is required, either from the participant or a legal guardian, following international guidelines.

2 medication administration

The study involves taking cenobamate, which is a medication used to help manage seizures.

Cenobamate is available in different forms and dosages: 10mg/mL oral suspension, 12.5mg tablet, 25mg tablet, and 50mg tablet.

A placebo, which looks like the medication but does not contain the active ingredient, may also be used for comparison.

3 medication schedule

The medication is taken orally, meaning it is swallowed.

The specific dosage and frequency will be determined by the study team based on individual needs and responses.

4 monitoring and assessments

Regular monitoring is conducted to ensure safety and to observe any side effects.

This includes checking vital signs, conducting physical and neurological examinations, and performing electrocardiograms (ECGs).

Laboratory tests are also done to monitor health status.

5 duration of participation

The study is designed to evaluate long-term safety, with an estimated end date in December 2026.

Participation continues as long as it is beneficial and safe, according to the study guidelines.

Who Can Join the Study?

  • The patient must have completed the Double-blind Treatment Period in the Core study. This means they participated in a part of the study where neither the patient nor the researchers knew who was receiving the actual treatment or a placebo.
  • The patient or their legal guardian must sign a written informed consent form before joining the study. This form explains the study and confirms that the patient agrees to participate.
  • If the legal guardian signs the consent form because the patient cannot, the patient must also give their agreement, either in writing or verbally.
  • The study is open to both male and female patients.
  • The study includes patients who are considered part of a vulnerable population, which means they might need extra protection or care.

Who Cannot Join the Study?

  • Patients who have a different type of seizure than Primary Generalized Tonic-Clonic Seizures cannot participate. These are a specific type of seizure that affects the whole brain.
  • Patients who are not within the specified age range cannot participate. The age range includes children, teenagers, and adults.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are taking certain medications that might interfere with the study cannot participate.
  • Patients who have a history of drug or alcohol abuse cannot participate.
  • Patients who have participated in another clinical trial recently cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
University Hospital Jena KöR Jena Germany
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Epilepsiezentrum Kleinwachau gGmbH Radeberg Germany
Im Mscah seumlz Bardejov Slovakia
Nhgwedsnyhvu Zykxub Ogdknp Zasodvwhcn &dceyak Cfdtazp Ndzwdlflyr Dtzlefwxqd i Lqhytbcl Pklogpro Kielce Poland
Kbzuavwpu sbobye Dubnica nad Váhom Slovakia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.07.2019
Hungary Hungary
Not recruiting
01.07.2019
Poland Poland
Not recruiting
01.07.2019
Slovakia Slovakia
Not recruiting
01.07.2019
Spain Spain
Not recruiting
01.07.2019

Trial locations

Investigated drugs:

Cenobamate is a medication being studied for its long-term safety when used as an additional treatment for people who experience primary generalized tonic-clonic seizures. This type of seizure involves the whole body and is often what people think of as a “grand mal” seizure. The study aims to see how well patients tolerate this medication over an extended period.

Primary Generalized Tonic-Clonic Seizures – These seizures involve sudden and widespread electrical activity in the brain, affecting both sides simultaneously. They typically begin with a loss of consciousness and muscle stiffening, followed by rhythmic jerking of the limbs. The person may cry out, fall, and experience muscle spasms, which can last for a few minutes. After the seizure, confusion, fatigue, and soreness are common as the brain recovers. These seizures can occur without warning and may be triggered by factors like sleep deprivation or stress. They are a type of generalized seizure, meaning they affect the entire brain from the onset.

Trial ID:
2023-506688-32-00
Protocol code:
YKP3089C033
Trial Phase:
Therapeutic confirmatory (Phase III)

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